Actively Recruiting

Age: 18Years +
All Genders
ID06777017

Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15

50

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the relationship between liver and spleen stiffness, measured by elastography, and the risk of hepatocellular carcinoma (HCC) coming back after treatment with radiofrequency ablation (RFA). This observational study also aims to explore whether these elastography values relate to overall survival, HCC-related survival, and risk of liver decompensation. Additionally, the study will assess connections between non-invasive biochemical tests and HCC recurrence risk in patients with chronic liver disease undergoing RFA. Participants are patients with chronic liver disease diagnosed with HCC who are candidates for RFA treatment. The study involves performing hepatic or splenic elastography using transient elastography (Fibroscan®) or Acoustic Radiation Force Impulse (ARFI) methods. Participants will be followed to observe the association of these elastography measurements with clinical outcomes after RFA treatment. During the study, participants will undergo elastography procedures to measure liver and spleen stiffness and provide biochemical test samples. The main outcome measured is the association between elastography values and HCC recurrence risk over 12 months following RFA. Researchers will also monitor overall and HCC-related survival and liver function status. The study is observational, with no additional interventions beyond routine care, and participation involves regular assessments and follow-up over the study period.

CONDITIONS

Brief Title

Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical-instrumental diagnosis of chronic liver disease
  • Indication for treatment of hepatocellular carcinoma with radiofrequency ablation using the Barcelona Clinic Liver Cancer staging system
  • Able to undergo hepatic or splenic elastography by transient method with Fibroscan® or ARFI method
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Diagnosis of hepatocholangiocarcinoma or other liver lesions besides hepatocellular carcinoma
  • History of liver transplantation or liver resection for hepatocellular carcinoma within the last two years
  • Liver disease in decompensation (Child-Pugh C) at consent or within three months prior to enrollment
  • Severe advanced diseases affecting short-term survival such as non-remission cancers, heart failure above NYHA III, chronic renal failure on dialysis, or lung disease requiring home oxygen therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 month

Participants undergo hepatic and splenic elastography measurements and biochemical tests to assess liver condition and risk factors.

1 to 2 visits depending on assessments

Long-term Monitoring

Duration - 12 months

Participants are observed for up to 12 months to monitor hepatocellular carcinoma recurrence and related health outcomes after radiofrequency ablation treatment.

Regular visits during follow-up as per clinical care

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

R

Rocco Maurizio Zagari, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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